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U-M receives NIH, FDA grant to study adaptive clinical trial designs
Date:10/7/2010

ANN ARBOR, Mich.Clinical trials in which participants are randomly assigned to different treatments by design are the cornerstone of clinical research. When conducted correctly, it's widely accepted by the research community that the results are valid and can be trusted.

But researchers at the University of Michigan hope to improve the process for bringing therapies and medical devices to patients by investigating the impact of a class of innovative trial designs known as adaptive clinical trials which make adjustments to the trial using information accumulated as patients are enrolled in hopes of improving the efficiency of clinical trials as a whole.

"One of the hard and firm rules of randomized clinical trials, and for good reason, is you can't just go changing your trial to get the results you want," says William Barsan, M.D., chair and director of the U-M Department of Emergency Medicine. "But with adaptive clinical trials, you spend a lot of time up-front asking yourself, 'What if?' so that any changes made throughout the course of the study are all agreed upon at the beginning, written into the study design and only changed throughout the course of the study based on pre-specified rules."

Researchers cannot always predict at what point a specific drug or treatment will show therapeutic results during the course of the study, if at all. Once a standard trial is underway, trial characteristics such as inclusion criteria cannot be modified or changed even if a sufficient amount of data collected before the trials end-date demonstrates that such changes may be necessary.

For example, remaining patients who are randomized to the placebo group cannot benefit from the therapeutic effect of the treatment, and money will continue to be spent until the trial ends. Current trials often include periodic review of data to search for early benefit or early harm but changes are usually only triggered when an overwhelming effec
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Contact: Jessica Soulliere
jesssoul@umich.edu
734-764-2220
University of Michigan Health System
Source:Eurekalert

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